FDA wants 33 percent budget increase

The Food and Drug Administration wants to increase its budget by a third — to $4.3 billion in fiscal 2012 — and spend $422 million on IT programs, officials said.

The proposed budget is $1 billion greater than the fiscal 2010 enacted level and includes $136 million for IT-related food regulation and food safety initiatives, according to FDA’s Justification of Estimates for Appropriations Committees document of Feb. 14.

“During FY 2012, FDA will achieve contract and administrative savings by increasing competition, using FDA-wide contracts to combine resources and reduce cost, replacing traditional classroom training with online training, achieving savings on information technology procurement, and reducing administrative support,” the budget document states.

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Several of FDA’s priorities include IT components. Officials want $218 million more to implement the Food Safety Modernization Act of 2010. That amount includes about $50 million for processes, data systems and analytical capabilities to coordinate reporting of food information from state and local providers and oversight agencies, the document states.

FDA officials also anticipate spending $97 million for IT systems related to human drug development and oversight; $59 million for IT systems related to medical devices; $56 million for systems related to oversight of biologics; $40 million for IT office infrastructure; and $24 million for IT systems for animal drug and feed oversight.

Other IT-related expenditures noted in the budget document include:

• $6.6 million for the Office of Science to support systems for surveillance and data mining of adverse events for regulated products and for activities related to developing unified, interoperable, information-sharing data systems among federal, state, and local agencies.
• Some $5 million for post-market surveillance systems.
• $1.9 million for information systems to support the regulatory pathway for new generic drugs.

FDA Commissioner Margaret Hamburg said the 33 percent increase in total FDA funding is needed for pressing priorities that include implementing a new food safety law, advancing development of vaccines against emerging diseases, fostering more generic drugs and strengthening medical research efforts.

FDA’s proposed budget includes a $694 million increase in user fees and $30 million in administrative and contracting cutbacks.